Surgical staples with expandable backspan

ABSTRACT

A surgical staple includes a body includes a first leg, a second leg, and a backspan. The backspan has a first portion, a second portion, a third portion, and a crimped region. The first portion of the backspan includes a looped member. The second portion of the backspan extends between a first end portion of the first leg and a first end portion of the looped member. The third portion of the backspan extends between a first end portion of the second leg and a second end portion of the looped member. The crimped region includes a crimped section in at least one of the second portion or the third portion of the backspan. A combined wire thickness of the second and third portions of the backspan in the crimped region is about equal to the diameter of the body of the surgical staple.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation in part of U.S. patent applicationSer. No. 15/587,747 filed May 5, 2017, and the disclosure of theabove-identified application is hereby incorporated by reference in itsentirety.

BACKGROUND 1. Technical Field

The present disclosure relates to surgical staples for use with surgicalstapling instruments. More particularly, the present disclosure relatesto surgical staples for use with surgical stapling instruments forjoining tissue of varying thicknesses.

2. Background of Related Art

Surgical staples are applied to tissue using surgical staplinginstruments to join tissue or tissue segments in a fast and efficientmanner in a variety of surgical procedures, e.g., anastomosesprocedures.

Typically, a surgical staple includes a backspan and a pair of spacedlegs. The legs are driven through tissue and into an anvil assembly of asurgical stapling instrument to deform the staple into a desiredconfiguration, e.g., B-staple, to effect hemostasis. Current surgicalstaples are particularly sized and suited for tissue of a giventhickness range to effect hemostasis. As such, a clinician must choose astaple having an appropriate size for a given tissue thickness range toensure effective hemostasis. If the tissue thickness is misidentified bythe clinician or if the tissue thickness falls near the outer edges ofthe range for a given staple size, the likelihood of ineffectivehemostasis is increased.

Accordingly, a continuing need exists in the suturing arts for asurgical staple that is capable of accommodating a greater range oftissue thicknesses to provide the clinician greater flexibility whenperforming a variety of surgical procedures.

SUMMARY

The present disclosure provides in one aspect a surgical stapleincluding a body having a diameter and including a first leg, a secondleg, and a backspan. The first and second legs each have a first endportion and a second end portion. The backspan has a first portion, asecond portion, a third portion, and a crimped region. The first portionof the backspan includes a looped member having a first end portion anda second end portion. The second portion of the backspan extends betweenthe first end portion of the first leg and the first end portion of thelooped member. The third portion of the backspan extends between thefirst end portion of the second leg and the second end portion of thelooped member. The crimped region includes a crimped section defined inat least one of the second portion or the third portion of the backspan.A combined wire thickness of the second and third portions of thebackspan in the crimped region is about equal to the diameter of thebody of the surgical staple.

In certain embodiments, the crimped region of the backspan includes afirst crimped section defined on the second portion of the backspan anda second crimped section defined on the third portion of the backspan.In such embodiments, the combined wire thickness of the crimped regionis about equal to the diameter of the body of the surgical staple.

In some embodiments, first crimped section of the second portion of thebackspan overlaps with the second crimped section of the third portionof the backspan.

In certain embodiments, the first crimped section of the second portionof the backspan is axially aligned with the second crimped section ofthe third portion of the backspan.

In some embodiments, the looped member of the backspan defines a firstaxis that extends between the first end portion of the looped member andthe second end portion of the looped member.

In certain embodiments, the second portion of the backspan defines asecond axis and the third portion of the backspan defines a third axis.In such embodiments, the first axis of the looped member is parallelwith the second axis of the second portion and the third axis of thethird portion.

In some embodiments, the second axis of the second portion of thebackspan is laterally aligned with the third axis of the third portionof the backspan such that the first leg and the second leg of thesurgical staple are axially aligned.

In certain embodiments, the looped member of the backspan includes anapex, the second portion of the backspan includes a first mid-portion,and the third portion of the backspan includes a second mid-portion. Insuch embodiments, the apex of the looped member and the first and secondmid-portions of the second and third portions of the backspan define anaxis that is perpendicular to the second axis of the second portion ofthe backspan and the third axis of the third portion of the backspan.

In some embodiments, the surgical staple includes an unformedconfiguration and a formed configuration. In the unformed configurationof the surgical staple, the apex of the looped member of the backspan isspaced apart from each of the second and third portions of the backspana first distance. In the formed configuration of the surgical staple,the apex of the looped member of the backspan is spaced apart from eachof the second and third portions of the backspan a second distance thatis less than the first distance.

In some embodiments, the backspan of the surgical staple is positionedto engage tissue such that the second distance between the apex of thelooped member of the backspan and each of the second and third portionsof the backspan decreases as a thickness of tissue engaged by thebackspan increases.

In certain embodiments, in the formed configuration of the surgicalstaple, the first leg of the surgical staple is positioned on a firstlateral side of the looped member and the second leg of the surgicalstaple is positioned on a second lateral side of the looped memberopposite the first lateral side of the looped member.

The present disclosure provides in another aspect a surgical stapleincluding a body having a first leg, a second leg, and a backspan. Thefirst and second legs each have a first end portion and a second endportion. The backspan has a first portion, a second portion, a thirdportion, and a crimped region. The first portion of the backspan has afirst end portion and a second end portion. The second portion of thebackspan extends longitudinally between the first end portion of thefirst leg and the first end portion of the first portion. The secondportion defines a first axis. The third portion of the backspan extendslongitudinally between the first end portion of the second leg and thesecond end portion of the first portion. The third portion defines asecond axis. The crimped region includes a crimped section defined in atleast one of the second portion or the third portion of the backspan.The crimped region aligns the first axis of the second portion with thesecond axis of the third portion.

In some embodiments, the first portion includes a looped memberpositioned between the first end portion and the second end portion ofthe first portion of the backspan.

In certain embodiments, the looped member of the first portion of thebackspan defines a third axis that is parallel with the first axis ofthe second portion of the backspan and the second axis of the thirdportion of the backspan.

In some embodiments, in the crimped region, the second and thirdportions of the backspan include a combined wire thickness that is aboutequal to a diameter of the body of the surgical staple.

In some embodiments, the crimped section defined in the at least one ofthe second portion or the third portion of the backspan axially alignsthe first end portion of the first leg with the first end portion of thesecond leg.

In certain embodiments, the crimped region of the backspan is disposedbetween the first end portion of the first leg and the first end portionof the second leg.

In certain embodiments, the second portion of the backspan and the thirdportion of the backspan are in lateral contact.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed expandable backspanstaples and cartridges for supporting the staples are disclosed hereinwith reference to the drawings, wherein:

FIG. 1 is a perspective view of an exemplary embodiment of the presentlydisclosed surgical staple, illustrating the surgical staple in aunformed configuration;

FIG. 2 is a front view of the surgical staple of FIG. 1;

FIG. 3 is a top view of the surgical staple of FIG. 1;

FIG. 4A is a front view of the surgical staple of FIG. 1 in a formedconfiguration engaging tissue having a first thickness;

FIG. 4B is a front view of the surgical staple of FIG. 1 in the formedconfiguration engaging tissue having a second larger thickness;

FIG. 4C is a front view of the surgical staple of FIG. 1 in the formedconfiguration engaging tissue having a third even larger thickness;

FIG. 5 is a perspective view of a surgical stapling instrument includinga cartridge that supports the surgical staples of FIG. 1 with a toolassembly of the surgical stapling instrument in an unclamped position;

FIG. 6 is a perspective view of a loading unit of the surgical staplinginstrument of FIG. 5 with the tool assembly of the loading unit in theunclamped position;

FIG. 7 is a perspective view of the tool assembly of FIG. 6 in theclamped position;

FIG. 8 is an exploded view of a staple cartridge assembly of the loadingunit of FIG. 6;

FIG. 9 is a top view of a staple cartridge of the staple cartridgeassembly of FIG. 8;

FIG. 10 is an enlarged view of the indicated area of detail delineatedas 10 in FIG. 9;

FIG. 11 is an enlarged view of the indicated area of detail delineatedas 11 in FIG. 8;

FIG. 12 is a side, perspective view of a pusher of the staple cartridgeassembly of FIG. 8;

FIG. 13 is a side, perspective view of the pusher of FIG. 12 with aplurality the surgical staples of FIG. 1 disposed on the pusher;

FIG. 14 is a top view of the pusher of FIG. 12;

FIG. 15 is a cross-sectional view taken along section lines “15-15” ofFIG. 7 with tissue having a first thickness clamped within the toolassembly of the loading unit; and

FIG. 16 is a cross-sectional view taken along section lines “16-16” ofFIG. 7 with tissue having a second thickness clamped within the toolassembly of the loading unit;

FIG. 17A is a perspective view of an exemplary embodiment of a surgicalstaple in accordance with another aspect of the present disclosure,illustrating the surgical staple in a unformed configuration;

FIG. 17B is a top view of the surgical staple of FIG. 17A;

FIG. 17C is a bottom view of the surgical staple of FIG. 17A;

FIG. 17D is a side view of the surgical staple of FIG. 17A;

FIG. 18 is a side, perspective view of a pusher of a staple cartridgeassembly in accordance with an aspect of the present disclosure thatsupports the surgical staples of FIG. 17A;

FIG. 19A is a side, perspective view of a staple cartridge assembly inaccordance with another aspect of the present disclosure that supportsthe surgical staples of FIG. 17A; and

FIG. 19B is a side, perspective view of a staple cartridge of the staplecartridge assembly of FIG. 19A.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed surgical staple will now bedescribed in detail with reference to the drawings wherein likereferences numerals identify similar or identical elements. In thedrawings, and in the following description, the term “proximal” shouldbe understood to refer to that portion or end of the instrument that isclosest to a user during proper use, while the term “distal” should beunderstood to refer to that portion or end of the instrument that isfurthest from a user during proper use, as is traditional andconventional in the art. Also, as used in the specification, the terms“approximately equal,” “substantially equal,” and “about equal” shouldbe understood to include +/−15% of a given parameter.

Referring initially to FIGS. 1-3, an exemplary embodiment of the presentdisclosure is shown generally as a surgical staple 100. The surgicalstaple 100 includes a body 10 having a backspan 12, a first leg 14, anda second leg 16. The surgical staple 100 has an unformed configuration,as shown in FIGS. 1-3, wherein the first leg 14 and the second leg 16are parallel, or substantially parallel, to one another and spaced adistance from one another. Alternatively, in the unformed configuration,the first and second legs 14, 16 can diverge slightly or convergeslightly, etc. in relation to each other.

Each of the first and second legs 14, 16 includes a first end portion 14a, 16 a, respectively, and a second end portion 14 b, 16 b,respectively. Each of the second end portions 14 b, 16 b of the firstand second legs 14, 16 includes a tissue-penetrating tip 14 c, 16 c. Inone embodiment, each of the tissue-penetrating tips 14 c, 16 c of therespective first and second legs 14, 16 of the surgical staple 100 canbe formed with beveled or tapered end to facilitate penetration of thefirst and second legs 14, 16 into tissue “T” (see FIGS. 4A-4C).Alternately, the tissue penetrating tips 14 c, 16 c of the respectivefirst and second legs 14, 16 of the surgical staple 100 need not betapered, can be tapered in a different direction, or can define aconical or flat surface.

With continued reference to FIGS. 1-3, the backspan 12 includes a firstportion 12 a having a looped member 18, a second portion 20 that issubstantially linear and extends between the first end portion 14 a ofthe first leg 14 and a first end portion 18 a of the looped member 18,and a third portion 22 that is substantially linear and extends betweenthe first end portion 16 a of the second leg 16 and a second end portion18 b of the looped member 18. The looped member 18 of the backspan 12includes an arcuate portion 24 that extends between the second and thirdportions 20, 22 of the backspan 12. In the unformed configuration of thesurgical staple 100, the second portion 20 of the backspan 12 may besubstantially parallel to the third portion 22 of the backspan 12 and inlateral contact or close alignment with the third portion 22 of thebackspan 12, as illustrated in FIG. 1.

In embodiments, the arcuate portion 24 of the looped member 18 extendstransversely between the second portion 20 and the third portion 22 ofthe backspan 12. In the unformed configuration of the surgical staple100, the second portion 20 of the backspan 12 defines an axis “X1-X1”and the third portion 22 of the backspan 12 defines an axis “X2-X2”. Theaxis “X1-X1” of the second portion 20 and the axis “X2-X2” of the thirdportion 22 may be laterally offset from each other an offset distance“OD”. It is envisioned that the offset distance “OD” between the axis“X1-X1” of the second portion 20 and the axis “X2-X2” of the thirdportion 22 may be substantially equal to a diameter “BD” of the body 10of the surgical staple 100 such that the second portion 20 and the thirdportion 22 are closely positioned or in contact with each other.

The arcuate portion 24 of the looped member 18 defines an axis “X3-X3”that extends between a first end portion 20 a of the second portion 20of the backspan 12 and a first end portion 22 a of the third end portion22 of the backspan 12. In embodiments, the looped member 18 and thesecond and third portions 20, 22 may define an enclosed opening 26 whichmay have a circular or oval configuration. It is envisioned that thearcuate portion 24 of the looped member 18 of the backspan 12 can beformed having any desired radius of curvature to suit a particular need,surgical procedure, or range of tissue thicknesses (as will be discussedbelow). It is also envisioned that the opening 26 defined by thebackspan 12 need not be circular or oval but rather may have otherconfigurations, such as, for example, U-shaped, trapezoidal,rectangular, etc. The backspan can have other shapes, such as round,rectilinear, etc., and the member 18 can be straight, angled or curved.Further, in embodiments, the backspan 12 may include more than onelooped member 18.

The body 10 of the surgical staple 100 can have a circular cross-sectionthroughout its length. Alternatively, it is envisioned that the body 10of the surgical staple 100 may have a variety of differentcross-sectional shapes including rectangular, oval, square, triangular,trapezoidal, etc. It is also envisioned that the backspan 12 of thesurgical staple 100 and the first and second legs 14, 16 of the surgicalstaple 100 may have different cross-sectional shapes. For example, inone embodiment, the backspan 12 of the surgical staple 100 can have arectangular cross-sectional shape and the first and second legs 14, 16of the surgical staple 100 can have an oval cross-sectional shape.

The surgical staple 100 may be fabricated from a formable material, suchas, for example, titanium, stainless steel or a variety of differentbio-compatible polymers. In this manner, the surgical staple 100 may beintroduced over tissue while in an unformed configuration, and thendeformed or fastened onto the tissue to secure the surgical staple 100to the tissue. It is contemplated that the surgical staple 100 may befabricated from any non-degradable, biocompatible material known bythose having skill in the art.

Referring now to FIGS. 4A-4C, in some embodiments, the first and secondlegs 14, 16 of the surgical staple 100 are deformed against an anvilassembly 1400 (see FIG. 5) of a surgical stapling instrument 1000 into asubstantially B-shaped staple configuration. Since the first and secondlegs 14, 16 of the surgical staple 100 extend from the second and thirdportions 20, 22 of the backspan 12, respectively, and the axis “X1-X1”of the second portion 20 and the axis “X2-X2” of the third portion 22are laterally offset from each other by the offset distance “OD,” whichis substantially equal to the diameter “BD” of the body 10 of thesurgical staple 100, it is envisioned that in the formed configurationof the surgical staple 100, the first leg 14 of the surgical staple 100is positioned on a first lateral side 24 a of the arcuate portion 24 ofthe looped member 18 and the second leg 16 is positioned on a second,opposite lateral side 24 b of the arcuate portion 24 of the loopedmember 18 (see FIGS. 3, 4A, and 4B).

In the formed configuration, the arcuate portion 24 of the looped member18 of the backspan 12 is configured to deform relative to the second andthird portions 20, 22 of the backspan 12, wherein the first and secondtransverse portions 20, 22 of the looped member 18 of the backspan 12remain substantially linear. Specifically, the deformation of thebackspan 12 of the surgical staple 100 is dependent upon a thickness,e.g., “T1,” “T2,” “T3,” etc., of the tissue “T” to be fastened.Initially, in the unformed configuration of the surgical staple 100, thelooped member 18 of the backspan 12 includes an uncompressed distance“D1” between an apex 24 c of the arcuate portion 24 of the looped member18 and the second and third portions 20, 22 of the backspan 12, asillustrated in FIG. 2. In some embodiments, it is contemplated that theapex 24 c of the arcuate portion 24 and a mid-portion “M1” (see FIG. 1)of the second portion 20 of the backspan 12 and a mid-portion “M2” (seeFIG. 1) of the third portion 22 of the backspan 12 defines an axis“X4-X4” that is substantially parallel to at least one of the first andsecond legs 14, 16 of the surgical staple 100 and/or substantiallyperpendicular to the axis “X1-X1” of the second portion 20 of thebackspan 12 and the axis “X2-X2” of the third portion 22 of the backspan12. Upon engagement with the tissue “T,” the looped member 18 of thebackspan 12 is compressed between the tissue “T” and anvil assembly 1400(see FIG. 5) of a surgical stapling instrument 1000 such that, thelooped member 18 of the backspan 12 defines a compressed distance “D2”between the apex 24 c of the arcuate portion 24 of the looped member 18and the second and third portions 20, 22 of the backspan 12, asillustrated in FIGS. 4A-4C. As the looped member 18 contacts tissue “T”positioned between the first and second legs 14 and the looped member 18as the staples 100 are deformed, the distance “”D2″ decreases an amountthat is directly related to the thickness of the tissue “T”. Morespecifically, as the thickness of the tissue increases, the forceapplied to the looped member 18 by the tissue “T” positioned between thefirst and second legs 14, 16 and the looped member 18 of the staples 100as the staples 100 are deformed increases, to increase the amount ofdeformation of the looped member 18.

FIG. 4A illustrates a staple 100 as the staple 100 is formed inrelatively thin tissue “T” having a first thickness “T1”. As the staple100 is deformed about relatively thin tissue “T” having a thickness“T1”, the tissue “T” is compressed between the first and second legs 14,16 and the looped member 18 of the staples 100. As the first and secondlegs 14, 16 of the staple 100 are deformed into a B-configurationagainst the anvil assembly 1400 of the surgical stapling instrument 1000(FIG. 5), the first and second legs 14, 16 push tissue “T” towards andagainst the looped member 18 of the backspan 12. Because the anvilassembly 1400 is disposed a fixed distance from the cartridge assembly1300 when the stapling instrument is fired (as described in detailbelow), all of the tissue “T” must fit between the first and second legs14, 16 and the looped member 18 of the backspan 12. Thus, where thetissue “T” is relatively thin, the tissue does not apply any substantialforces onto the looped member 18 as the first and second legs 14, 16 aredeformed and little or no deformation to the looped member 18 occurs.Thus, the distance “D2” between the apex 24 c of the arcuate portion 24of the looped member 18 and the second and third portions 20, 22 of thesurgical staples 100 remains substantially unchanged or only decreasesslightly. Referring to FIG. 4B, where the tissue “T” has a moderatethickness of “T2”, the tissue “T” requires more space between the firstand second legs 14, 16 and the looped member 18 of the backspan 12.Thus, as the first and second legs 14, 16 are deformed against the anvilassembly 1400 and the tissue “T” is pushed towards the looped member 18of the backspan 12, a greater force is applied to the looped member 18to cause greater amount of deformation of the looped member 18 of thebackspan 12. Thus, the distance “D2” between the apex 24 c of thearcuate portion 24 of the looped member 18 and the second and thirdportions 20, 22 of the backspan 12 of the surgical staple 100 decreasesa moderate amount. Similarly, where the tissue “T” has a large thicknessof “T3” as shown in FIG. 4C, the tissue “T” requires even more spacebetween the first and second legs 14, 16 and the looped member 18 of thebackspan 12 as the staple 100 is deformed. Thus, as the first and secondlegs 14, 16 are deformed against the anvil assembly 1400 and the tissue“T” is pushed towards the looped member 18 of the backspan 12, an evengreater force is applied to the looped member 18 to cause a greateramount of deformation of the looped member 18 of the backspan 12 tofurther reduce the distance D2″ between the apex 24 c of the arcuateportion 24 of the looped member 18 and the second and third portions 20,22 of the backspan 12 of the surgical staple 100.

As illustrated in FIGS. 4A-4C, it is envisioned that the arcuate portion24 of the looped member 18 of the backspan 12 becomes progressively morelinear as the thickness of the tissue “T” increases. The ability of thebackspan 12 of the surgical staple 100 to deform in accordance with therelative thickness of the tissue “T” facilitates the use of thepresently disclosed staples with tissue having a wider range ofthicknesses while providing effective hemostasis.

In order to place the presently disclosed surgical staple 100 in thetissue “T,” a surgical apparatus in the form of the surgical staplinginstrument 1000 is provided, as illustrated in FIG. 5. The surgicalstapling instrument 1000 is approximated and fired similarly to, and inaccordance with other known surgical stapling instrument, for example,the surgical stapling instrument disclosed in U.S. Pat. No. 5,865,361,the entire content of which is incorporated herein by reference.

As illustrated in FIG. 5, the surgical stapling instrument 1000generally includes a handle assembly 1002 with a movable handle 1003 aand a stationary handle 1003 b, an elongated shaft 1004 extendingdistally from the handle assembly 1002, and a loading unit 1008 that iscoupled to a distal portion of the elongated shaft 1004. In any of theembodiments disclosed herein, the handle assembly can include, or beattached to, one or more motors, or could be configured to work with asurgical robotic system.

With reference to FIGS. 6-8, the loading unit 1008 of the surgicalstapling instrument 1000 includes a tool assembly 1200 having a staplecartridge assembly 1300 housing a plurality of surgical staples 100 (seeFIG. 8) and an anvil assembly 1400 movably secured in relation to thestaple cartridge assembly 1300 such that the tool assembly 1200 ismovable between an open configuration (see FIG. 6) where the staplecartridge assembly 1300 is spaced apart from the anvil assembly 1400,and a clamped configuration (see FIG. 7) where the staple cartridgeassembly 1300 and the anvil assembly 1400 are approximated. Alternately,the cartridge assembly 1300 can be movably supported in relation to theanvil assembly 1400.

Turning now to FIG. 8, the staple cartridge assembly 1300 includes acarrier 1310 having an elongated support channel 1312. The elongatedsupport channel 1312 is dimensioned and configured to receive a staplecartridge 1314. The staple cartridge assembly 1300 includes a pair ofelastic or resilient members 1316 a, 1316 b that are configured anddimensioned to apply and maintain a constant compressive force to thetissue “T” positioned between the staple cartridge assembly 1300 and theanvil assembly 1400 (see FIGS. 15 and 16) of the tool assembly 1200. Inembodiments, the pair of elastic or resilient members 1316 a, 1316 b maybe configured as two substantially parallel, elongate members that arepositioned between the staple cartridge 1314 and a pair of shoulders1318 a, 1318 b formed on the carrier 1310, respectively. The pair ofelastic members 1316 a, 1316 b may be attached to, or otherwise disposedon, the pair of shoulders 1318 a, 1318 b of the carrier 1310, and may befixedly or releasably attached thereto in alternative embodiments. Thepair of elastic members 1316 a, 1316 b is configured to compress toaccommodate tissues of different thicknesses between the cartridgeassembly 1300 and the anvil assembly 1400. For a more detaileddescription of the construction and operation of an example of the pairof elastic members 1316 a, 1316 b, reference may be made to U.S. Pat.No. 8,152,041, the entire content of which is incorporated herein byreference.

The staple cartridge 1314 of the staple cartridge assembly 1300 includesa plurality of staple pockets 1320 that are arranged in rows. Theplurality of staple pockets 1320 are dimensioned for receiving theplurality surgical staples 100 and a plurality of pushers 1322, as willbe detailed below. The staple cartridge assembly 1300 includes anactuation sled 1324 movably supported with in the elongated supportchannel 1312 of the carrier 1310. During operation, the actuation sled1324 is configured to advance along the elongated support channel 1312of the carrier 1310 to sequentially contact the plurality of pushers1322, such that the plurality of pushers 1322 are displaced within theplurality of staple pockets 1320 to eject the plurality of surgicalstaples 100 from the plurality of staple pockets 1320 towards the anvilassembly 1400.

As detailed above with reference to FIGS. 1-4C, the axis “X1-X1” of thesecond portion 20 of the backspan 12 and the axis “X2-X2” of the thirdportion 22 of the backspan 12″ are laterally offset from each other bythe offset distance “OD”. In order to compensate for the laterallyoffset orientation of the backspan 12 of the surgical staple 100 andensure that the first and second legs 14, 16 of each of the plurality ofsurgical staples 100 are longitudinally aligned relative to the otherplurality of surgical staples 100 in a corresponding row of surgicalstaples 100, the plurality of staple pockets 1320 of the staplecartridge 1314 and a plurality of staple seats 1326 of the plurality ofpushers 1322 are dimensioned and shaped as detailed below.

Specifically, with reference to FIGS. 9-11, each of the plurality ofstaple pockets 1320 of the staple cartridge 1314 includes a contour “C”that corresponds to the orientation of the surgical staple 100 as shownin the top view of the surgical staple 100 in FIG. 3. The contour “C” ofthe staple pocket 1320 of the staple cartridge 1314 includes a firstportion “C1” that is shaped and dimensioned to receive the first leg 14of the surgical staple 100, a second portion “C2” that is shaped anddimensioned to receive the second leg 16 of the surgical staple 100, andan intermediate portion “C3” positioned between the first portion “C1”and the second portion “C2” that is shaped and dimensioned to receivethe backspan 12 of the surgical staple 100. The plurality of staplepockets 1320 of the staple cartridge 1314 are skewingly positionedrelative to a longitudinal axis “A-A” of the staple cartridge 1314 suchthat the first and second legs 14, 16 of each of the plurality ofsurgical staples 100 are longitudinally aligned relative to the otherplurality of surgical staples 100 in the corresponding row of surgicalstaples 100.

With reference to FIGS. 12-14, each of the plurality of staple seats1326 of the plurality of pushers 1322 is adapted for releasablyreceiving the backspan 12 of the surgical staple 100. The staple seat1326 of the pusher 1322 is skewingly positioned relative to alongitudinal axis “B-B” of the pusher 1322, as illustrated in FIG. 14.It is envisioned that the skewed configuration of the staple seat 1326of the pusher 1322 is adapted to align the surgical staple 100 with theskewingly positioned staple pocket 1320 of the staple cartridge 1314, asthe surgical staple 100 is ejected through the staple pocket 1320towards the anvil assembly 1400, as illustrated in FIGS. 10, 15, and 16.Specifically, the staple seat 1326 of the pusher 1322 includes a firstwall 1326 a projecting from a first portion 1326 b of the staple seat1326 and towards the staple pocket 1320 of the staple cartridge 1314,and a second wall 1326 c projecting from a second portion 1326 d of thestaple seat 1326 and towards the staple pocket 1320 of the staplecartridge 1314. The first and second walls 1326 a, 1326 c of the stapleseat 1326 of the pusher 1322 defines a skewed channel 1328 extendingbetween the first and second portions 1326 b, 1326 d of the staple seat1326 of the pusher 1322. The skewed channel 1328 of the staple seat 1326is skewingly positioned relative to the longitudinal axis “B-B” of thepusher 1322.

When the surgical staple 100 is located on the staple seat 1326 of thepusher 1322, the first wall 1326 a of the staple seat 1326 is configuredto engage the second portion 20 of the backspan 12 and the second wall1326 b of the staple seat 1326 is configured to engage the third portion22 of the backspan 12 to releasably receive the backspan 12 of thesurgical staple 100. Since the skewed channel 1328 of the staple seat1326 is skewingly positioned relative to the longitudinal axis “B-B” ofthe pusher 1322, it is envisioned that when the surgical staple 100 islocated on the staple seat 1326 of the pusher 1322, the surgical staple100 is skewingly positioned relative to the longitudinal axis “B-B” ofthe pusher 1322, as illustrated in FIGS. 13 and 14.

Turning now to FIGS. 8, 9, 15, and 16, in embodiments, the plurality ofstaple pockets 1320 are arranged in rows on lateral sides of a knifeslot 1330 extending through the staple cartridge 1314 of the staplecartridge assembly 1300. The knife slot 1330 is configured toaccommodate movement of a knife 1332, or other such cutting element tosever the tissue “T” (see FIGS. 4A-4C) disposed between the staplecartridge assembly 1300 and the anvil assembly 1400. In embodiments, theknife slot 1330 may extend along a centerline “CL” of the staplecartridge 314 of the staple cartridge assembly 1300, as illustrated inFIG. 8. Alternatively, the knife slot 1330 may be laterally offset fromthe centerline “CL” of the staple cartridge 1314 of the staple cartridgeassembly 1300.

With reference to FIGS. 15 and 16, the anvil assembly 1400 includes acorresponding knife slot 1402 on a tissue-facing surface 1404 of theanvil assembly 1400 that is configured to accommodate movement of theknife 1332. In embodiments, the knife 1332 includes an I-beamconfiguration such that a top portion 1332 a of the knife 1332 ismovably disposed within the knife slot 1402 of the anvil assembly 1400and a bottom portion 1332 b of the knife 1332 is movably disposed withinthe knife slot 1330 of the staple cartridge 1314 of the staple cartridgeassembly 1300. In any of the embodiments disclosed herein, the knife canhave other shapes, or could be part of or attached to the sled.

With continued reference to FIGS. 15 and 16, the knife 1332 includes aheight “H”. When the staple cartridge assembly 1300 and the anvilassembly 1400 are approximated and the knife 1332 is translated throughthe respective knife slots 1330, 1402, the height “H” of the knife 1332provides for a constant distance “D3” between the anvil assembly 1400and each of the plurality of staple seats 1326 of the plurality ofpushers 1322, regardless of the thickness of the tissue “T” (see FIGS.4A-4C) disposed between the staple cartridge assembly 1300 and the anvilassembly 1400 and regardless of the positioning of the staple cartridge1314. The height “H” of the knife 1332 also provides for a maximumtissue gap when the knife 1332 is translated through the respectiveknife slots 1330, 1402.

Referring now to FIGS. 5-16, in operation, the surgical staplinginstrument 1000 is manipulated such that the tissue “T” is disposedbetween the staple cartridge assembly 1300 and the anvil assembly 1400with the tool assembly 1200 spaced-apart, in the open configuration (seeFIG. 6). The staple cartridge assembly 1300 and the anvil assembly 1400are then approximated by actuating the movable handle 1003A of thehandle assembly 1002 to clamp the tissue “T” disposed between the staplecartridge assembly 1300 and the anvil assembly 1400 such that acompressive force is applied to the tissue “T”.

With the tissue “T” securely clamped between the staple cartridgeassembly 1300 and the anvil assembly 1400, the surgical staplinginstrument 1000 is then fired to eject the plurality of surgical staples100 by actuating the movable handle 1003A. Upon firing the surgicalstapling instrument 1000, the actuation sled 1324 (FIG. 8) advancesalong the elongated support channel 1312 of the carrier 1310 tosequentially contact the plurality of pushers 1322, such that theplurality of pushers 1322 are displaced within the plurality of staplepockets 1320 to eject the plurality of surgical staples 100 from theplurality of staple pockets 1320 towards the anvil assembly 1400.

The plurality of surgical staples 100 pass through the plurality ofstaple pockets 1320 of the staple cartridge 1314 (see FIG. 8) andthrough the tissue “T”. After passing through the tissue “T,” theplurality of surgical staples 100 engage the tissue-facing surface 1404of the anvil assembly 1400 and are deformed into the substantiallyB-staple configuration (see FIGS. 4A-4C). Upon formation within thetissue “T,” the plurality of surgical staples 100 maintain a compressiveforce on the tissue “T” to effect hemostasis.

Sequential firing of the surgical staples 100 continues until theactuation sled 1324 is advanced to a distal end of the staple cartridge1314, at which time all of the plurality of surgical staples 100 housedthe staple cartridge 1314 will have been ejected. The knife 1332 maythen be translated through the tool assembly 1200 to form an incisionbetween the rows of stapled tissue “T”.

Turning now to FIGS. 17A-17D, an exemplary embodiment of a surgicalstaple in accordance with another aspect of the present disclosure isshown generally as surgical staple 200. The surgical staple 200 issubstantially similar to the surgical staple 100 disclosed above (seeFIGS. 1-4C) and will therefore be described only to the extent necessaryto highlight the differences.

As shown in FIG. 17A, the surgical staple 200 includes a body 210 havinga backspan 212, a first leg 214, and a second leg 216. Each of the firstand second legs 214, 216 includes a first end portion 214 a, 216 a,respectively, and a second end portion 214 b, 216 b, respectively. Eachof the second end portions 214 b, 216 b of the first and second legs214, 216 includes a tissue-penetrating tip 214 c, 216 c. The surgicalstaple 200 has an unformed configuration, as shown in FIGS. 17A, whereinthe first leg 214 and the second leg 216 are parallel, or substantiallyparallel, to one another and spaced a distance from one another.Alternatively, in the unformed configuration, the first and second legs214, 216 can diverge slightly or converge slightly, etc. in relation toeach other.

The backspan 212 includes a first portion 212 a including a loopedmember 218, a second portion 212 b that is substantially linear andextends between the first end portion 214 a of the first leg 214 and afirst end portion 218 a of the looped member 218, and a third portion212 c that is substantially linear and extends between the first endportion 216 a of the second leg 216 and a second end portion 218 b ofthe looped member 218.

With reference to FIGS. 17A and 17C, in embodiments, the second andthird portions 212 b, 212 c of the backspan 212 defines a crimped region220 disposed between the first end portion 214 a of the first leg 214and the first end portion 216 a of the second leg 216. In embodiments,the crimped region 220 includes a first crimped section 220 a formed onthe second portion 212 b of the backspan 212 and a second crimpedsection 220 b formed on the third portion 212 c of the backspan 212. Inembodiments, the first crimped section 220 a overlaps or is axiallyaligned with the second crimped section 220 b. Alternatively, it iscontemplated that the crimped region 220 may be defined by a crimpedsection in only one of the second and third portions 212 b, 212 c of thebackspan 212. In the crimped region 220, the second and/or the thirdportions 212 b, 212 c of the backspan 212 are flattened such that acombined wire thickness “WT” of the first and second crimped sections220 a, 220 b of the backspan 212 is approximately equal to a diameter“BD2” of the body 210 of the surgical staple 200. In embodiments, thecrimped region 220 of the backspan 212 may be formed by compressing thesurgical staple 200 between two substantially flat surfaces via anysuitable means.

With additional reference to FIG. 17B, forming the crimped region 220 inthe surgical staple 200 aligns an axis “X5-X5” of the second portion 212b with an axis “X6-X6” of the third portion 212 c. Further, forming thecrimped region 220 in the surgical staple 200 aligns an axis “X7-X7” ofthe first portion 212 a with the axis “X5-X5” and the axis “X6-X6” ofthe second and third portions 212 b, 212 c of the backspan 212,respectively. As a result, the first leg 214 of the surgical staple 200is axially aligned with the second leg 216 of the surgical staple 200such that the surgical staple 200 is provided with a slim profile asshown in FIG. 17D.

In embodiments, the surgical staple 200 may be used with a knownsurgical stapling instrument, such as, for example, the surgicalstapling instrument disclosed in U.S. Pat. No. 5,865,361, the entirecontent of which was previously incorporated herein by reference. Withreference to FIG. 18, the surgical stapling instrument disclosed in the'361 patent may include conventional pushers such as, for example, aplurality of pushers 2322. In contrast to the skewed configuration ofthe plurality of pushers 1322 described above (see FIG. 13), each of theplurality of pushers 2322 includes staple seats 2326 that are linear andconfigured to support the crimped region 220 of a respective surgicalstaple 200. The slim profile of the surgical staple 200 (see FIG. 17D)also enables the surgical staple 200 to be received through conventionalretention slots of a staple cartridge as disclosed in the '361 patent.Thus, it is contemplated that the surgical staple 200 may be usedinterchangeably with a conventional surgical staple without requiringmodifications to the plurality of pushers 2322 or the staple cartridgeas disclosed in the '361 patent.

Referring also to FIGS. 4A-4C, as discussed above in regard to thesurgical staple 100, the surgical staple 200 may be positioned adjacentthe tissue “T” while in an unformed configuration, and then deformed orfastened onto the tissue such that the surgical staple 200, in a formedconfiguration, defines a substantially B-shaped staple configuration. Inorder to place the surgical staple 200 in the tissue “T,” a surgicalapparatus similar to the surgical stapling instrument 1000 (see FIG. 5)disclosed above, and the surgical stapling instrument disclosed in the'361 patent may be used.

With reference to FIGS. 19A and 19B, the slim profile (see FIG. 17D) ofthe surgical staple 200 also enables a plurality of surgical staples 200to be disposed in a stacked orientation, and provided for use with acartridge assembly 3000 similar to the In-Situ Loaded cartridge assemblydisclosed in U.S. Pat. No. 9,364,217, the entire content of which isincorporated herein by reference.

The cartridge assembly 3000 generally includes a first staple cartridge3020, a second staple cartridge 3040, and a plurality of staple pockets3060 associated with each of the first and second staple cartridges3020, 3040. Although FIG. 19B only illustrates the first staplecartridge 3020, each of the first and second staple cartridges 3020,3040 includes a plurality of staple magazines 3070 and a plurality ofpushers 3080 operatively associated with the plurality of staple pockets3060. Each of the plurality of staple magazines 3070 is configured toreceive the plurality of surgical staples 200 such that the plurality ofsurgical staples 200 is disposed therein in the stacked orientation.Once the plurality of surgical staples 200 is loaded into the pluralityof staple magazines 3070, the plurality of pushers 3080 is configured tourge the plurality of surgical staples 200 out through the plurality ofstaple pockets 3060 as disclosed in '217 patent. It is contemplated thatthe plurality of surgical staples 200 may be used interchangeably with aplurality of conventional staples as disclosed in the '217 patentwithout requiring modifications to the cartridge assembly 3000.

In any of the embodiments disclosed herein, the tool assembly can beincorporated with the elongate portion of the handle assembly. Thestaple cartridge can be a removable and replaceable assembly, in aninstrument with a replaceable loading unit or tool assembly orincorporated tool assembly.

The surgical staples described herein can be utilized in a configurationwhere the backspan is not intended to be deformed. In certainembodiments, the backspan can be configured to house a material orobject, with a deformable backspan or a backspan that is not deformable.The material or object can include medically useful materials such as ahemostat or sealant, pharmaceuticals such as chemotherapy agents, andeven radio-active agents such as brachytherapy particles or seeds. Suchmaterials or objects can be disposed in the opening formed by the loopedmember or incorporated in a mesh, woven, braided, non-woven material, ora suture, that is disposed in the looped member.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, the above described staplemay be formed from any of a variety of surgically acceptable materialsincluding titanium, plastics, resorbable materials, etc. Therefore, theabove description should not be construed as limiting, but merely asexemplifications of preferred embodiments. Those skilled in the art willenvision other modifications within the scope and spirit of the claimsappended hereto.

What is claimed is:
 1. A surgical staple comprising: a body having adiameter, the body including: a first leg having a first end portion anda second end portion; a second leg having a first end portion and asecond end portion; and a backspan including: a first portion having alooped member, the looped member including a first end portion and asecond end portion; a second portion extending between the first endportion of the first leg and the first end portion of the looped member;a third portion extending between the first end portion of the secondleg and the second end portion of the looped member; and a crimpedregion including a crimped section defined in at least one of the secondportion and the third portion of the backspan, wherein a combined wirethickness of the second and third portions of the backspan in thecrimped region is about equal to the diameter of the body of thesurgical staple.
 2. The surgical staple according to claim 1, whereinthe crimped region includes a first crimped section defined on thesecond portion of the backspan and a second crimped section defined onthe third portion of the backspan, wherein the combined wire thicknessof the crimped region is about equal to the diameter of the body of thesurgical staple.
 3. The surgical staple according to claim 2, whereinthe first crimped section of the second portion of the backspan overlapswith the second crimped section of the third portion of the backspan. 4.The surgical staple according to claim 3, wherein the looped member ofthe backspan defines a first axis that extends between the first endportion of the looped member and the second end portion of the loopedmember.
 5. The surgical staple according to claim 4, wherein the secondportion of the backspan defines a second axis and the third portion ofthe backspan defines a third axis, the first axis of the looped memberbeing parallel with the second axis of the second portion and the thirdaxis of the third portion.
 6. The surgical staple according to claim 5,wherein the second axis of the second portion of the backspan islaterally aligned with the third axis of the third portion of thebackspan such that the first leg and the second leg of the surgicalstaple are axially aligned.
 7. The surgical staple according to claim 5,wherein the looped member of the backspan includes an apex, the secondportion of the backspan includes a first mid-portion, and the thirdportion of the backspan includes a second mid-portion, the apex of thelooped member and the first and second mid-portions of the second andthird portions of the backspan defining an axis that is perpendicular tothe second axis of the second portion of the backspan and the third axisof the third portion of the backspan.
 8. The surgical staple accordingto claim 2, wherein the first crimped section of the second portion ofthe backspan is axially aligned with the second crimped section of thethird portion of the backspan.
 9. The surgical staple according to claim1, wherein the surgical staple includes an unformed configuration and aformed configuration, wherein in the unformed configuration of thesurgical staple, the apex of the looped member of the backspan is spacedapart from each of the second and third portions of the backspan a firstdistance, and wherein in the formed configuration of the surgicalstaple, the apex of the looped member of the backspan is spaced apartfrom each of the second and third portions of the backspan a seconddistance less than the first distance.
 10. The surgical staple accordingto claim 9, wherein the backspan of the surgical staple is positioned toengage tissue such that the second distance between the apex of thelooped member of the backspan and each of the second and third portionsof the backspan decreases as a thickness of tissue engaged by thebackspan increases.
 11. The surgical staple according to claim 9,wherein in the formed configuration of the surgical staple, the firstleg of the surgical staple is positioned on a first lateral side of thelooped member and the second leg of the surgical staple is positioned ona second lateral side of the looped member opposite the first lateralside of the looped member.
 12. A surgical staple comprising: a bodyincluding: a first leg having a first end portion and a second endportion; a second leg having a first end portion and a second endportion; and a backspan including: a first portion including a first endportion and a second end portion; a second portion extendinglongitudinally between the first end portion of the first leg and thefirst end portion of the first portion, the second portion defining afirst axis; a third portion extending longitudinally between the firstend portion of the second leg and the second end portion of the firstportion, the third portion defining a second axis; and a crimped regionincluding a crimped section defined in at least one of the secondportion or the third portion of the backspan, wherein the crimped regionaligns the first axis of the second portion with the second axis of thethird portion.
 13. The surgical staple according to claim 12, whereinthe first portion includes a looped member positioned between the firstend portion and the second end portion of the first portion.
 14. Thesurgical staple according to claim 13, wherein the looped member of thefirst portion of the backspan defines a third axis that is parallel withthe first axis of the second portion of the backspan and the second axisof the third portion of the backspan.
 15. The surgical staple accordingto claim 12, wherein in the crimped region, the second and thirdportions of the backspan include a combined wire thickness about equalto a diameter of the body of the surgical staple.
 16. The surgicalstaple according to claim 12, wherein the crimped section defined in theat least one of the second or third portions of the backspan axiallyaligns the first end portion of the first leg with the first end portionof the second leg.
 17. The surgical staple according to claim 12,wherein the crimped region of the backspan is disposed between the firstend portion of the first leg and the first end portion of the secondleg.
 18. The surgical staple according to claim 12, wherein the crimpedregion includes a first crimped section defined on the second portion ofthe backspan and a second crimped section defined on the third portionof the backspan.
 19. The surgical staple according to claim 18, whereinthe first crimped section of the second portion overlaps with the secondcrimped section of the third portion.
 20. The surgical staple accordingto claim 18, wherein the first crimped section of the second portion isaxially aligned with the second crimped section of the third portion,and wherein the second and third portions of the backspan are in lateralcontact.